FDA 510(k) Applications Submitted by AL ALEXANDER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K031757 |
06/06/2003 |
PEEK TETRIS SPINAL IMPLANT |
SIGNUS MEDICAL LLC. |
| K080349 |
02/11/2008 |
KIMBA MINI |
SIGNUS MEDIZINTECHNIK GMBH |
| K103434 |
11/23/2010 |
3B FLEX-LITE |
3B PRODUCTS, LLC |
| K241177 |
04/29/2024 |
React 71 Catheter |
Micro Therapeutics lnc. d/b/a ev3 Neurovascular |
| K110025 |
01/03/2011 |
SECTRA MICRODOSE MAMMOGRAPHY |
SECTRA IMTEC AB |
| K220563 |
02/28/2022 |
Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System |
Arthrocare Corporation |
| K242094 |
07/17/2024 |
Dreem 3S |
Beacon Biosignals, Inc. |
| K142352 |
08/22/2014 |
CardiacLinx |
Ross Medical Technology, Inc |
| K982821 |
08/11/1998 |
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7 |
MULTIMEDIA MEDICAL SYSTEMS, INC. |
| K092467 |
08/12/2009 |
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED |
BRAINLAB AG |
| K220394 |
02/11/2022 |
SmartAdjust(TM) technology |
Insulet Corporation |
| K241777 |
06/20/2024 |
SmartAdjustÖ Technology |
Insulet Corporation |
| K222239 |
07/26/2022 |
SmartBolus Calculator |
Insulet Corporation |
| K232741 |
09/07/2023 |
SmartAdjust(TM) technology |
Insulet Corporation |
| K203768 |
12/23/2020 |
Omnipod 5 ACE Pump (Pod) |
Insulet Corporation |
| K203774 |
12/23/2020 |
SmartAdjust technology |
Insulet Corporation |
| K121277 |
04/27/2012 |
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE |
Z-MEDICAL GMBH & CO. KG |
| K143200 |
11/06/2014 |
MIS Z-Pedicle Screw System |
Z-Medical GmbH & Co. KG |
| K142953 |
10/10/2014 |
OCT-Camera |
OptoMedical Technologies GmbH |
| K242259 |
07/31/2024 |
Cala kIQ |
Cala Health, Inc. |
| K243848 |
12/16/2024 |
Cala kIQ |
Cala Health, Inc. |
| K070580 |
03/01/2007 |
NASOPHARYNGOSCOPE, BRONCHOSCOPE |
XION GMBH |
| K231256 |
05/01/2023 |
Carecube Negative Pressure Isolation Chamber |
Carecubes, Inc. |
| K171254 |
04/28/2017 |
LeEject 2 Dental Syringe and Needle System |
Advanced Technology and Capital, Inc. |
| K212164 |
07/12/2021 |
Mapping Suction Probe |
inomed Medizintechnik GmbH |
| K222570 |
08/23/2022 |
COPAL knee moulds |
Heraeus Medical GmbH |
| K050317 |
02/09/2005 |
BURANE XL |
WAVELIGHT LASER TECHNOLOGIE AG |
| K071183 |
04/30/2007 |
ALLEGRO OCULYZER |
WAVELIGHT AG |
| K051399 |
05/31/2005 |
WAVELIGHT AURIGA |
WAVELIGHT LASER TECHNOLOGIE AG |
| K052806 |
10/04/2005 |
BURANE |
WAVELIGHT LASER TECHNOLOGIE AG |
| DEN210013 |
03/30/2021 |
OsteoProbe |
Active Life Scientific, Inc. |
| K221195 |
04/25/2022 |
OsteoProbe |
Active Life Scientific, Inc. |
| K062068 |
07/21/2006 |
INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 |
INTELWAVE, LLC |
| K143446 |
12/02/2014 |
Accu-Chek FlexLink Plus infusion set |
Roche Diagnostics GmbH |
| K231566 |
05/31/2023 |
ICX-Implant System |
Medentis Medical GmbH |
| K223290 |
10/26/2022 |
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) |
SentiAR, Inc. |
| K183605 |
12/26/2018 |
Spine & Trauma Navigation |
Brainlab AG |
| K110021 |
01/03/2011 |
DASH HIP |
BRAINLAB, AG |
| K100038 |
01/07/2010 |
DISPOSABLE REFLECTIVE MARKER SPHERES |
BRAINLAB, AG |
| K110204 |
01/24/2011 |
BRAINLAB TRAUMA |
BRAINLAB AG |
| K190250 |
02/07/2019 |
Microscope Navigation |
Brainlab AG |
| K120520 |
02/21/2012 |
EXACTRAC ROBOTICS NOVALIS ROBOTICS |
BRAINLAB AG |
| K120789 |
03/15/2012 |
EXACTRAC X-RAY X-RAY |
BRAINLAB AG |
| K141199 |
05/09/2014 |
QUENTRY DOSE REVIEW |
BRAINLAB AG |
| K101627 |
06/09/2010 |
IPLAN |
BRAINLAB AG |
| K122011 |
07/09/2012 |
NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP |
BRAINLAB AG |
| K122225 |
07/25/2012 |
STERILE RADIOLUCENT SKULL PINS |
BRAINLAB AG |
| K142108 |
08/04/2014 |
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS |
BRAINLAB AG |
| K102251 |
08/09/2010 |
DASH KNEE |
BRAINLAB AG |
| K122451 |
08/13/2012 |
EXACTRAC VERO |
BRAINLAB AG |
| K132763 |
09/04/2013 |
ADVANCED VIEWER |
BRAINLAB, AG |
| K172820 |
09/18/2017 |
Microscope Navigation Software |
Brainlab AG |
| K102990 |
10/08/2010 |
BRAINLAB KNEE |
BRAINLAB AG |
| K103246 |
11/03/2010 |
IPLAN RT |
BRAINLAB, AG |
| K113732 |
12/19/2011 |
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) |
BRAINLAB AG |
| K243190 |
09/30/2024 |
USTOMED Bone Fixation/Bone Augmentation Systems - PIN |
Ustomed Instrumente Ulrich Storz GmbH & Co. KG |
| K101759 |
06/23/2010 |
QUANTUM RING FIXATION SYSTEM MODEL ISF |
QUANTUM MEDICAL CONCEPTS, LLC. |
| K230894 |
03/31/2023 |
NuVasive Modulus ALIF System |
NuVasive, Incorporated |
| K223903 |
12/28/2022 |
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) |
Semperit Investments Asia PTE LTD. |
| K221303 |
05/05/2022 |
Neuspera Nuity System |
Neuspera Medical Inc. |
| K202781 |
09/22/2020 |
Neuspera Neurostimulation System (NNS) |
Neuspera Medical Inc. |
| K051093 |
04/28/2005 |
OSTEOPORE PCL SCAFFOLD |
OSTEOPORE, INC. |
| K172157 |
07/18/2017 |
DePuy Synthes Femoral Recon Nail System |
Synthes (USA) Products, LLC |
| K030261 |
01/24/2003 |
BATTERY, RECHARGEABLE |
ACCESS BATTERY, INC. |
| K091548 |
05/27/2009 |
AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
| K032051 |
07/02/2003 |
BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P |
ACCESS BATTERY, INC. |
| K082528 |
09/02/2008 |
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM |
NOBLE ANESTHESIA-AIR, INC. |
| K072596 |
09/14/2007 |
LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
| K082861 |
09/29/2008 |
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
| K974414 |
11/24/1997 |
MULTI |
MORNING CALM CORP. |
| K972816 |
07/29/1997 |
ADVANCED TREATMENT PLANNING SYSTEM |
ADVANCED RADIATION THERAPY SYSTEMS, INC. |
| K140424 |
02/19/2014 |
RESPIRONICS REUSABLE HEATED TUBING |
RESPIRONICS, INC. |
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